A080 IRB Analyst

Cameo Consulting Group, LLC, a management consulting practice based out of Alexandria, VA, is seeking multiple qualified and available Protocol Coordinators to support a potential Federal client specializing in Veteran healthcare research initiatives in Washington, DC. The positions are full-time, long-term in nature, and available upon contract award.

GENERAL DUTIES:

Administrative Helpdesk Support

• Provide administrative helpdesk support to ORPP&E.
• Transfer questions and responses received from mailboxes into FAQ database monthly.
• Maintain mailboxes, to include organizing and collating questions and responses and purging redundant questions monthly.
• Add govt email addresses of individuals to the various listservs

Meeting and Training Support: Education and Training

• Provide administrative support to ORPP&E’s education and training program.
• Schedule and conduct tech walks with first time webinar presenter webinars.
• Send emails requesting availability for a tech walk before the webinar to ensure tech walks occur for all presenters before the day of the scheduled webinar.
• Assist with administering/hosting webinars using web-based platforms, including adding requisite information to the webinar platform.
• Assist with post webinar activities, to include preparing survey and data analytics generated from the webinar platform, to include attendee registration information, attendance records, questions submitted, response to post-webinar evaluation surveys and sending webinar recordings, associated handouts, presenter information, key words used to tag each webinar for search functionality, and transcripts to webmaster for posting.
• Provide administrative support to the VAIRRS Program.
• Schedule project management and workgroup session meetings.
• Maintain workgroup rosters and coordinate availability of workgroup members and meeting participants for workgroup and project management meetings, respectively.
• Solicit agenda topics from meeting participants; prepare and disseminate meeting agendas; attend meetings, track open tasks/action items; and prepare meeting minutes.
• Schedule monthly webinars, obtaining webinar materials from presenters and attending webinars and managing presentations as necessary.
• Draft monthly program updates, update and maintain SharePoint site;
• Monitor and respond to questions received in the VAIRRS program mailbox;
• Draft revisions forms and templates based on input received during document review sessions, tracking changes made to forms and templates, and maintaining a list of the most current versions of all forms.

Protocol Review and Processing

• Support the VA CIRB by processing new study submissions and managing post-approval monitoring (amendments, continuing review, and reportable events) for all assigned human subjects research studies. T
• All documents produced by and in support of the VA CIRB are written clearly, concisely, and incorporate all required regulatory and VA policy requirements.
• Use the approved IRBNet and VA CIRB platform for managing research studies
• Manage PI applications and Local Site Applications from all local participating sites for the assigned study
• Perform administrative and technical reviews of assigned study applications to identify missing or incomplete documentation and to highlight areas that may be deficient or require clarification.
• Complete required review forms and communicate findings to the study team and/or assigned IRB members as necessary.
• Coordinate review of the study submission among the study team and assigned IRB members to include information security, regulatory, privacy, and VA Central IRB voting primary, secondary, and informed consent reviewers, ensuring that all reviews are completed in a timely manner, summarizing comments, and contacting the study team to request additional information and/or changes to the project or forms.
• Maintain a complete file of all submitted study documents, results of all reviews by assigned reviewers, and all correspondence in accordance with VA CIRB SOPS and other regulatory requirements.
• Prepare interim and final letters to the study team for actions eligible for expedited review, notifying all relevant parties, including but not limited to the national study team, all local participating sites, local participating research offices, and coordinating centers, of the results of each review and the regulatory basis for requested changes, until the study team has satisfied all identified reviewer and regulatory concerns and a final approval letter from the IRB is issued.
• Ensure all databases and tracking logs are kept up to date
• Manage communication with, and provides advice and guidance to Principal Investigators, Study Chairs, and Study Teams, throughout all stages of the study, from application submission to conclusion of the study.
• Manage all post-approval monitoring activities as assigned by IRB Management staff to include the processing of modifications to approved studies, continuing review or annual reports as required, and the processing of reportable event reports to include unanticipated problems, protocol deviation and violations, local RCO and other audit reports, and complaints.
• Provide support to during meetings by attending meetings, tracking attendance throughout the duration of the meeting, and taking detailed notes during the meeting.
• Prepare meeting minutes.

VA Central IRB Support – Administrative Support

• Assist with revising VA CIRB SOPs as requested by VA Central IRB management personnel.
• Assist with updating forms, checklists, templates, and reports used by the VA CIRB as requested by VA Central IRB Management personnel.
• Perform file audits for CRIB Principal Investigator protocols on an annual basis.
• Protocols to be audited will be designated by VA Central IRB Management personnel.
• Assist with preparing for oversight inspections and site visits as necessary.
• Answer calls received on national VA Central IRB toll free line, logging in calls, and providing and appropriate response or forwarding the call to VA Central IRB staff

Regulatory and Policy Support

• Assist with implementation of Cooperative Research Provision/Single IRB Requirement
• Provide administrative support to cooperative research provision/single IRB program.
• Ensure that all checklists and other required documents for the Non-Institutional Review Board Application Process are included in the application process, entering applications into the tracking system, and routing documents appropriately to required reviewers.
• Maintain and track records of the status of IRB reliance agreements and Federal Wide Assurance (FWA) for non-VA Institutional Review Board including maintaining a database of IRB reliance agreements executed, modified, renewed, or terminated.
• Maintain a database of the status of Federal Wide Assurances for any non-VA IRB used by a VA Facility

QUALIFICATIONS:

• 3 years’ experience in IRB performing reviews of non-exempt human subject research.
• Familiarity with the functions of the Institutional Review Board (IRB), the Common Rule, and FDA regulations.
• Experience using MS Access
• Ability to pass background check. Prior Government Clearance preferred.
• Bachelor’s Degree preferred

OTHER DESIRED QUALIFICATIONS:

• Positive attitude
• Critical thinking skills
• Accountable for actions
• Customer service mentality
• Takes Responsibility for Work Products
• Excellent communication and writing skills
• Ability to separate the issue/problem from the person
• Ability to work independently AND work as a team member

PLACE OF PERFORMANCE:

A mix of onsite at VA facilities in Washington, DC, telework, and occasional support at corporate office in Alexandria, VA.

HOURS OF OPERATION:

General business hours, typically 8-430 (with flexibility, M-F.

ABOUT CAMEO:

Cameo provides a competitive benefit package to its employees that is replete with training programs and continuous education features that few others even attempt to duplicate. Our packages are offered to all full-time exempt employees on day one* and they offer many standard features one would expect to find from an industry leader, the details of which are outlined in our handbook. Below is a highlight of our benefit offerings:

• 401K Plan
• Tuition Reimbursement
• 3 Weeks Paid Time Off
• 10 Paid Federal Holidays
• Jury Duty and Bereavement Leave
• Medical Insurance - Multiple Nation-Wide Coverage Options
• Dental Insurance - 100% Employer covered for Employee
• Vision Insurance - 100% Employer covered for Employee
• Life Insurance Package - 100% covered by Employer
• Short-Term and Long-Term Disability Insurance Options
• Corporate Shopping Perks from TicketsatWork.com
• Employee Referral Bonus for Tough-to-Fill posts
• Free annual membership to professional organization of choice (i.e. NCMA, PMI)